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Effects of Peptamen 1.6 in Malnourished Patients (or at Risk) With Pancreatic Neoplasia Undergoing Cephalic Pancreaticoduodenectomy (CPD): A Mechanistic Study
Condition(s) studied
Pancreatic Cancer, AdultCephalic Duodenopancreatectomy
Investigational drug(s) / intervention(s)
Dietary Supplement: Experimental Treatment with nutritional suplement A + nutritional suplement BDietary Supplement: Dietary Supplement: Experimental Treatment with nutritional suplement B + nutritional suplement A
Dietary Supplement: Experimental Treatment with nutritional suplement A + nutritional suplement B: Intervention group will receive a nutritional formula A and, after 1-week washout period, will receive a nutritional formula B
Dietary Supplement: Dietary Supplement: Experimental Treatment with nutritional suplement B + nutritional suplement A: Intervention group will receive a nutritional formula B and, after 1-week washout period, will receive a nutritional formula A
Study summary
Malnutrition is a common challenge in patients with pancreatic cancer undergoing cephalic pancreaticoduodenectomy (CPD), impacting postoperative recovery and overall prognosis. Nutritional support plays a crucial role in optimising metabolic, inflammatory, and digestive outcomes. This randomised, double-blind, crossover clinical trial aims to evaluate the effects of Peptamen 1.6, a hydrolysed whey protein-based enteral formula, compared to Resource HP/HC, a high-protein and high-calorie polymeric formula, in malnourished or at-risk patients with pancreatic cancer undergoing PD.
The study comprises both in vivo and in vitro analyses. The in vivo component will assess the impact of Peptamen 1.6 on digestive tolerance, amino acid absorption, nutritional status, metabolic profile, inflammatory markers, and gut microbiota composition. The in vitro component will utilise human intestinal organoid models to explore how enteral nutrition formulations influence intestinal permeability and metabolism, with a focus on microbiota interactions.
Primary outcomes include improvements in metabolic status, assessed through serum biomarkers (albumin, immune markers, intestinal permeability, and myosin profile), inflammatory status via peripheral blood mononuclear cells (PBMCs), and microbiota shifts in faecal samples. Additionally, adherence to treatment, digestive tolerance, and changes in body composition will be monitored using bioelectrical impedance, dynamometry, and functional mobility tests.
By elucidating the mechanisms through which different enteral nutrition strategies influence clinical, physiological, and molecular parameters, this study aims to enhance personalised nutritional interventions for patients with pancreatic cancer. The findings could contribute to optimising nutritional support strategies, ultimately improving patient outcomes following CPD.
Eligibility
Inclusion Criteria:
* Ambulatory patients who are malnourished or at risk of malnutrition, with a confirmed diagnosis of neoplasms of the periampullary region, pancreas, and duodenum, or pancreatic cancer, and who have undergone cephalic pancreaticoduodenectomy (CPD).
* No prior neoadjuvant treatment (preoperative chemotherapy or radiotherapy): Patients must not have received neoadjuvant therapy as these treatments can affect metabolism, nutritional status, and gut microbiota, potentially interfering with the objectives of the study's nutritional intervention.
Exclusion Criteria:
* Refusal to sign informed consent: Informed consent is a mandatory requirement for study participation. Any patient unwilling to participate voluntarily will be excluded.
* Patients who underwent surgery more than three months ago will be excluded, as the nutritional intervention must begin in the immediate postoperative period to adequately evaluate its impact on nutritional and metabolic status.
* Presence of severe cardiac disease, nephropathy, or other severe comorbidities: Conditions such as severe cardiac disease, renal failure, or comorbidities that could induce malnutrition or impair the patient's ability to tolerate nutritional treatment will be exclusion criteria. These conditions may interfere with assessing the effects of nutritional supplementation in the context of pancreatic cancer treatment.
* Diarrhoea associated with antibiotics, laxatives, or osmotically active agents: Diarrhoea caused by medications may alter nutrient absorption and affect tolerance to the nutritional supplement, potentially skewing results attributable solely to the nutritional intervention.
* Treatment with other nutritional support: Patients receiving other oral nutritional supplement, enteral or parenteral nutrition will be excluded, as interactions with the studied formula could confound the efficacy results of the study's nutritional intervention.
* Pregnancy or possibility of becoming pregnant.
* Type 1 or Type 2 diabetes with HbA1c \>8%.
* Galactosaemia, fructosaemia, or allergies to components of the nutritional supplement.
Primary outcome measure(s)
- Adherence to nutritional treatment — At weeks 6 and 13
Categorized based on the average daily consumption compared to the prescribed volume (200 ml per bottle):
* Full content (200 ml/bottle)
* 2/3 content (150 ml/bottle)
* 1/2 content (100 ml/bottle)
* 1/4 content (50 ml/bottle)
Patients will self-report their average daily consumption (ml/day).
- Natural food intake — At weeks 6 and 13
Patients will report their food intake over the previous week, categorized into quartiles (%) relative to:
* Pre-illness consumption
* Perceived normal intake for patients without supplementation
* ALL -100%
* 3/4 - 75%
* HALF - 50%
* ¼ - 25%
* NONE - 0%
- Tolerance to nutritional treatment — At weeks 6 and 13
Evaluated based on the frequency of gastrointestinal symptoms (e.g., nausea, vomiting, reflux, abdominal pain, flatulence, satiety, constipation, and stomach heaviness) within two hours of supplement consumption.
Symptoms classified as:
* Never
* Rarely
* Sometimes
* Frequently
* Always
Bivariate analysis will classify tolerance as:
* Good (no symptoms)
* Poor (presence of any gastrointestinal symptoms)
- Change in aminoacids: Ala, Glu, Asp, Pro, Phe, Leu/Ile, Val, Tyr, Met, Cit, Arg, Gly, and Orn — At baseline and in weeks 6, 7, and 13
Aminoacids measured in µmol/L
- Change in IL-6 and TNF-alpha RNA expression — At baseline and in weeks 6, 7, and 13
IL-6 and TNF-alpha measured from Peripheral blood mononuclear cell (PBMC)
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Hospital Regional Universitario de Málaga |
Málaga |
Málaga |
Recruiting |
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